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In this first of a series of articles we're going to discuss a specific type of patent called a business method patent.

If a company develops a new method for cond

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ucting an e-commerce business they may be able to prevent other companies from using this method for almost twenty years.

The truth is, since 1998 an increasing nu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

mber of software and Internet companies have been issued patents for designing new ways of doing business. Examples would be new online ordering processes or a uni

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ue Internet advertising method. These kind of patents which are usually the combination of software and business methods are called business method patents or Inte

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rnet patents.

The reason these patents are important is because a company that develops such a patent can keep other companies from using these business methods fo

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

17 years. And if the owner wants, he can make additional money from the patent by licensing out to other companies. If there is a large enough market, the compan

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

y may make more money from the licenses than from the patent itself.

A very good example of a business method patent is Amazon.com's 1-click payment method. This

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ystem allows a customer to bypass the traditional address and credit card forms as long as the customer has an account with Amazon. After clicking on the payment b

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

utton the order automatically goes through. This patent was granted to Amazon.com in September 1999. The patent number is U.S. Pat No. 5,960,411.

Business meth

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

d patents are actually a part of a larger family of patents called utility patents. These protect inventions, chemical formulas, processes and other discoveries.

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

A business method is technically classified as a process. The reason is because it is not a physical object like a machine or some form of chemical compound.

Duri

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ng most of the last century the patent office issued very few business method patents. The reason for this is that they claimed that a process could not be patente

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

if it was an abstract idea. The same thing was also said about software because software was said to be unpredictable algorithms.

That all changed in 1998. In J

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

uly of that year a federal court upheld a patent for a method of calculating the net asset value of mutual funds. The court ruled that patent laws were intended to

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

protect any method regardless of what it was, even an idea. As long as it produced a useful, concrete and tangible result. With this ruling the court made idea an

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

d software patents a reality again. After this ruling, business method patents increased by 40%. Also, that year, the U.S. Patent and Trademark Office created a n

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

w classification for business method patents. The classification is stated as "Data processing: financial, business practice, management or cost/price determinatio

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

n."

Many patents since this time have been issued for online shopping programs, Amazon's 1-click being the best example. However, because of the gray area of thes

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

patents, not having a physical product, an additional layer of review was added to the patent determination process. Technology specialists have been hired specif

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ically to review these type of patent applications.

In the next article in this series we're going to discuss how to go about applying for a business method patent

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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